
GxP Compliant System Manager
1 week ago
The eCompliance Manager is responsible for ensuring the quality of computerized systems within the organization. This involves providing Quality Assurance oversight and guidance with regard to CSV operating within the framework of regulations, such as GxP and 21CFR11. The eCompliance Manager also provides operational support in approving GxP impacted changes, Periodic Review Reports, deviations, etc.
Key Responsibilities include: Quality oversight of operational activities of GxP systems, such as Changes, Periodic Reviews, Deviations, etc. Provide needed support to meet applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.
This role requires a solid understanding of global regulations and Health Authorities expectations governing computerized systems, CSV, Part 11, etc. Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments is also essential.
The ideal candidate will have a degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent. A minimum of 10-15 years of overall IT experience, including 7 years of relevant experience in the Pharmaceutical Industry and particularly within regulated functions such as IT Quality and Compliance is required.
Skills and Qualifications:
- 10-15 years of overall IT experience
- Minimum 7 years of relevant experience in the Pharmaceutical Industry
- Solid understanding of global regulations and Health Authorities expectations governing computerized systems
- Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments
- Good understanding of system application management, its Quality support approach and industry best practices
- ITIL, ITSM, etc.
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